Kornimate/medical-research-clean huggingface dataset:
a multicenter, post marketing clinical follow up (pmcf) investigation to evaluate the performance and safety of a soft silicone foam dressing and to evaluate the performance of standard care in exuding venous leg ulcers

Conditions: Venous Leg Ulcer (VLU)

Summary: this investigation is a post marketing follow-up study for mepilex xt conducted as part of mölnlycke health care's quality system. the primary objective is to evaluate the performance of the dressing when used as intended on exuding venous leg ulcers (vlus) in the inflammatory and granulating stages of the wound healing process.


Eligibility criteria:
inclusion criteria: 1. venous leg ulcer 2. exuding wound 3. wound surface covered with sloughy tissue\* (before debridement) 4. wound size ≥ 6 cm2 5. in case of multiple wounds, target wound must be ≥ 3cm distant from other wounds. 6. wound suitable for treatment with the relevant primary dressing\*\* 7. male or female, 18 years of age and above 8. signed informed consent * sloughy tissue defined as wet, yellow-brown fibrinous tissue present in the wound bed \*\* mepilex xt in the intervention group. standard care in the observation group exclusion criteria: 1. more than two products of 15 cm x15 cm needed to cover the whole wound and affected peri-wound area 2. wound cavity and/or fistula 3. full thickness burns 4. exposed tendons and/or fascia 5. bleeding wounds 6. malignant or fungating wounds 7. wound age \> 12 months 8. use of antimicrobial dressings or topical agents such as antiseptics, local antibiotics and steroids within 7 days from inclusion on the wound intended to be included 9. untreated limb ischemia (according to investigator's judgement) at the time of inclusion 10. subject not suitable for the investigation according to the investigator's judgement 11. subject included in other ongoing clinical investigation which could interfere with this investigation, as judged by the investigator 12. known allergy/hypersensitivity to any of the components of the primary dressing
evaluation of robot-assisted total knee arthroplasty with automatic balancing

Conditions: Osteoarthritis, Knee

Summary: the goal is to evaluate the outcomes and learning curve of a robot-assisted total knee arthroplasty device with automatic ligament balancing.


Eligibility criteria:
inclusion criteria: * end stage osteoarthritis of the knee joint with failed conservative treatment exclusion criteria: * previous ligament trauma of the mcl/lcl * previous fracture of femur or tibia * fixed flexion contracture \> 10° * flexion \< 110° * coronal deformity \> 15° * previous infection of the knee joint * ligament insufficiency * neurologic conditions
thoracic paravertebral blocks using a combination of ropivacaine and dexmedetomidine

Conditions: Thoracic Paravertebral Blocks

Summary: the investigators designed a study to assess whether thoracic paravertebral blocks using a combination of ropivacaine and dexmedetomidine prolong nerve block duration.

the investigators designed a study to assess whether thoracic paravertebral blocks using a combination of ropivacaine and dexmedetomidine prolong nerve block duration. the effects of dexmedetomidine have only been compared at lower doses. this trial examined the effect of greater dose of dexmedetomidine on thoracic paravertebral block analgesia duration.

Eligibility criteria:
inclusion criteria: * patients were included in the study if they were ethnic chinese, * american society of anesthesiologists (asa) physical status i or ii, * candidates for general anesthesia undergoing thoracic surgery exclusion criteria: * patients were excluded if they do not want to cooperate with the test, * had a history of radial artery puncture or coronary artery bypass grafting, * had acute vessel trauma,or had been diagnosed with raynaud' disease, * had suffered from mental or neurological disorders
the medacta quadra-p anteverted study

Conditions: Arthrosis; Traumatic Arthritis; Rheumatoid Polyarthritis; Congenital Hip Dysplasia; Avascular Necrosis of the Femoral Head

Summary: this is a post-marketing surveillance of quadra-p anteverted stem prosthesis.

the primary objective of this study is to evaluate the 10-year survival of the anteverted quadra-p stem in patients operated for primary total hip arthroplasty, according to the inclusion criteria. secondary objectives: * to assess clinical performance by harris hip score collected during preoperative and postoperative visits at 3 months, 1, 2, 5, 7 and 10 years. * assess radiological performance by standard radiographic examination performed preoperatively, postoperatively before discharge and during postoperative visits at 3 months, 1, 2, 5, 7 and 10 years. * assessing the patient's perception of the prosthetic joint by means of fjs questionnaire collected during the preoperative visit and postoperative visits at 3 months and at 1, 2, 5, 7 and 10 years after surgery. * assessment of functional recovery by gait analysis study * collect the rate of complications throughout the course of the study

Eligibility criteria:
inclusion criteria: * subjects suffering from primary hip arthrosis, post-traumatic arthrosis, dysplasia or avascular necrosis of the femoral head, rheumatoid arthritis * adult subjects between 18 and 75 years of age on the date of surgery * subjects eligible for primary total hip arthroplasty surgery for whom the anterior quadra-p femoral component will be implanted according to the indications for use of the implant * subjects who are willing and able to provide written informed consent for participation in the study. written informed consent must be obtained prior to surgery. for the anatomical-functional subgroup: - adult subjects aged between 18 and 65 years at the date of surgery who have agreed to undergo the gait analysis study. exclusion criteria: * subjects with acute or chronic infection * subjects with a femoral neck fracture * subjects with mental conditions that impair their ability to consent to the study, to complete required questionnaires or to complete follow-up visits * subjects with severe deformities, at the discretion of the surgeon * subjects with metabolic disorders that may involve bone metabolism for which an uncemented implant would be contraindicated * subjects with muscular atrophy or neuromuscular diseases * subjects allergic to the materials used during surgery * subjects unable or unwilling to provide consent for participation in the study * any other condition not mentioned in the inclusion criteria

Keywords: total hip arthroplasty quadra p anteverted medacta
vasopressin versus epinephrine in myomectomy

Conditions: Uterine Myomas

Summary: uterine myomas (fibroids or leiomyomas) are the most common benign tumor of the female genital tract and the leading indication for hysterectomy. although hysterectomy is the definitive treatment of myomas, myomectomy remains the gold standard treatment for women desiring future fertility and uterine conservation3. however, bleeding is often a problem in myomectomy and can results in intraoperative hypovolemic shock, postoperative anemia, pelvic infection, and adhesions with infertility. a number of interventions have been introduced to reduce hemorrhage during myomectomy. two categories of interventions can be identified: (a) vascular interventions on uterine and/or ovarian arteries such as artery clamping, tying, or embolization; (b) pharmacologic interventions such as vasopressin, epinephrine, oxytocin, ergometrine, misoprostol, sulprostone, and gonadotropin-releasing hormone (gnrh) agonist4-11. of these, intraoperative local injection of vasopressin causing vasospasm is most commonly used. however, there is not a wide consensus on the use of this agent because of serious side effects reported in literature. in addition, in several countries, including france and italy, vasopressin has not been commercialized because of its potential adverse effects on cardiovascular system. epinephrine also induces a vasoconstrictive effect on tissue that lasts longer than that of vasopressin (5-6 hours versus 7-35 minutes) and is used during various gynecological surgeries, endoscopic resection, and dermatologic procedures to reduce blood loss. however, there are a few studies for the use of epinephrine to reduce hemorrhage during myomectomy. furthermore, a randomized comparison of epinephrine and vasopressin as hemostatic agents during myomectomy has never been conducted. to test the hypothesis that the injections of epinephrine and vasopressin during myomectomy are equivalent in reducing blood loss, the investigators performed this randomized controlled study.


Eligibility criteria:
inclusion criteria: * women who had myoma-related symptoms such as menorrhagia, pelvic pressure/pain, or infertility * women who were not pregnant at the time of presentation (i.e., negative for urine pregnancy test or last menstrual period within the last 4 weeks) * women who were appropriated medical status for laparoscopic surgery (american society of anesthesiologists physical status classification 1 or 2). exclusion criteria: * any pelvic abnormalities requiring concomitant surgery * the presence of pedunculated subserosal or submucosal myoma as a dominant myoma * the presence of myoma of maximum diameter 10 cm based on the preoperative ultrasound * more than 4 myomas * treatment of gnrh agonist or unipristal acetate within 3 months before surgery * an inability to understand and provide written informed consent.
clinical study to evaluate the efficacy of ectoin® containing eye spray for treatment of dry eye disease

Conditions: Dry Eye

Summary: subjective and objective evaluation of the efficacy and tolerability of preservative-free "ectoin® eye spray - colloidal" and comparison of the efficacy and tolerability between "ectoin® eye spray - colloidal" and tears again® in patients with mild-moderate dry eye disease

"dry eye is a multifactorial disease of the ocular surface characterized by a loss of homeostasis of the tear film, and accompanied by ocular symptoms, in which tear film instability and hyperosmolarity, ocular surface inflammation and damage, and neuro- sensory abnormalities play etiological roles." (dews ii report, 2017). for the treatment and prevention of dry eye disease (ded) there are a number of treatment modalities available, depending on the severity and classification (aqueous deficient / evaporative) of the disease. the liposomal eye spray tears again® (ta, optima medical swiss ag - medical device with ce marking) represents an option to treat mild to moderate evaporative ded. a novel preservative-free eye spray, ectoin® eye spray - colloidal (ees09; bitop ag -medical device with ce marking), was developed, in which colloids (colloidal lecithin emulsion) serve as a carrier for ectoin. ectoin is known as a natural cell-protective and inflammatory-inhibiting molecule. the principle mode of action of ectoin is based on the physical interaction of this compatible solute with water and the resulting effects of the ectoin-hydro-complex on the tissue treated. the aim of this study is to subjectively and objectively evaluate the efficacy and tolerability of preservative-free "ectoin® eye spray - colloidal" and to compare the efficacy and tolerability between "ectoin® eye spray - colloidal" and tears again® in patients with mild-moderate dry eye disease.

Eligibility criteria:
inclusion criteria: * minimum age 18 years * osdi score of at least 18 * nibut smaller or equal to 10s in at least one eye exclusion criteria: * post-operative trauma or injury * ocular disease with exception of ded * hypersensitivity to any of the ingredients in the products used for this study * contact lens wear 24h before or on the day of study visits * use of eye drops / other eye sprays on the day of visit 1 or during the duration of the study period

Keywords: dry eye eye spray
safety and tolerability of dabigatran etexilate in adolescents

Conditions: Venous Thromboembolism

Summary: to investigate the safety and tolerability of dabigatran etexilate capsules in a small group of eight adolescent patients.


Eligibility criteria:
inclusion criteria: 1. males or females 12 to less than 18 years of age 2. objective diagnosis of primary vte 3. completion of planned treatment course with lmwh or oac for primary vte 4. written informed consent by parent (legal guardian) and patient assent exclusion criteria: 1. weight less than 32 kg 2. conditions associated with increased risk of bleeding 3. severe renal dysfunction or requirement for dialysis 4. active infective endocarditis 5. hepatic disease 6. pregnant females or females not using medically accepted contraceptive method 7. anemia or thrombocytopenia 8. use of prohibited or restricted drug within previous week 9. received investigational drug within past 30 days 10. unreliable patients or patients who have any condition that would not allow safe participation in study
prevention of inappropriate icd shocks

Conditions: Inappropriate ICD Therapy; Appropriate ICD Therapy

Summary: the aim of the present study is to investigate whether increasing detection zones can effectively reduce inappropriate icd therapies in primary prevention patients.


Eligibility criteria:
inclusion criteria: * \> 18 years * cardiomyopathy (ischemic or not) * current accepted indication for icd implantation exclusion criteria: * previous device implantation * secondary prevention patients * pregnancy, * primary electrical disorders, * patient refusal, * \<1 year of expected mortality
a small-molecule carbonic anhydrase ix targeting pet tracer in clear cell renal cell carcinoma

Conditions: Clear Cell Renal Cell Carcinoma

Summary: the goal of this pilot clinical trial is to see the potential application of a caix targeted pet. tracer in patients with clear cell renal cell carcinoma. the main question\[s\] it aims to answer are: * the biodistribution of the pet tracer * whether rcc lesions can be identified by the pet tracer participants will undergo 68ga-ny104 pet/ct scan and images will be reviewed by nuclear medicine specialists.

pet/ct imaging of three patients using 68ga-ny104 for medical reasons will be performed. patients received an intravenous injection of 68ga-ny104. images will be obtained at 0.5 h, 1 h, and 2 h after injection. a comparative 18f-fdg pet/ct scan will also be performed if necessary. the study will be carried out on a time-of-flight pet/ct scanner. suvmax and suvmean of normal organs and lesions, as well as tumor-to-background ratios, will be quantitatively assessed using a region-of-interest technique.

Eligibility criteria:
inclusion criteria: 1. confirmed or suspected metastatic ccrcc 2. age ≥ 18 y 3. written informed consent provided for participation in the trial 4. in the opinion of investigator, willing and able to comply with required study procedures. exclusion criteria: 1. patients on vegf tki treatment \< 1 week before 68ga-ny104 pet/ct. tki is known to affect girentuximab binding in patients with ccrcc. if patients were on vegf tki treatment, such as sunitinib, sorafenib, cabozantinib, pazopanib, or lenvatinib, a washout of one week before 68ga-ny104 pet/ct is required. 2. pregnancy or breastfeeding. 3. severe claustrophobia.
a study to learn about dacomitnib in patients with non-small cell lung cancer which has spread to the brain.

Conditions: Carcinoma, Non-Small-Cell Lung

Summary: the purpose of this study is to learn about dacomitinib for the possible treatment of lung cancer which has spread to other parts of the body. this study is seeking participants who: * have lung cancer that has reached at least the brain. * have a type of gene called epidermoid growth factor receptor. a gene is a part of your dna that has instructions for making things your body needs to work. * have not received any treatment before. all participants in this study will receive dacomitnib 1 time a day. dacomitinib is a tablet that is taken by mouth at home. they can continue to take dacomitnib until their cancer is no longer responding. the study will look at the experiences of people receiving the study medicine. this will help to see if the study medicine is safe and effective.


Eligibility criteria:
inclusion criteria: * at least 18 years old * confirmed diagnosis of egfr mutation-positive nsclc * at least one measurable intracranial metastasis * ecog-ps of 0, 1 or 2 * dacomitinib as first-line treatment for advanced nsclc * evidence of a personally signed and dated informed consent document (icd) exclusion criteria: * any anti-cancer systemic treatment within 12 months prior to index date * currently on active investigational drug(s) treatment in other clinical studies (phase 1-4) within 2 weeks before the current study begins and/or during study participation.

Keywords: dacomitinib, non-small cell lung cancer, brain metastasis
comparative effectiveness of fit, colonoscopy, & usual care screening strategies

Conditions: Colorectal Cancer

Summary: colorectal cancer (crc) is the 2nd leading cause of cancer death in the us, though crc death can be reduced by screening. however, there is uncertainty as to which screening strategy is most clinically and cost-effective from a population perspective where the aim is to optimize completion of the entire screening process continuum. modeling studies suggest benefits and harms of colonoscopy and stool blood test strategies are similar, but generally assume 100% participation and subsequent clinically appropriate follow up--something never achieved in clinical practice. comparative effectiveness studies of testing strategies, including comparisons of specific tests and approaches to optimizing effective test use, are necessary. safety-net health systems care for populations at increased risk for adverse crc outcomes, such as the uninsured and minorities, and have more limited resources. therefore, safety-nets must resolve the uncertainty regarding the most effective screening strategy. the investigators will conduct a system-level, randomized comparative effectiveness trial of the benefits, harms, and costs of 3 screening strategies over 3 years, among 6000 patients age 50-64 years, who are not up-to-date with crc screening, served by a large safety net health system. the three strategies studied will be: 1) fecal immunochemical testing, with annual mailed invitation outreach (including a test kit), and a centralized process to promote participation and complete clinical follow up (fit); 2) colonoscopy, with annual mailed invitation outreach, and a centralized process to promote participation and complete clinical follow up (colo); 3) usual care, with no mailed invitation outreach, and screening offered at primary care visits. the primary measure of benefit will be an outcome measure that summarizes patient-specific effective screening successes. the primary measure of harm will be screening non-participation. the primary measure of cost will be cost per-patient effectively screened. our specific aims are to: 1) compare benefits, harms, and costs of a fit strategy versus a colo strategy for crc screening among patients not up-to-date with screening, and 2) compare benefits, harms, and costs of a) the fit strategy vs. usual care and b) the colo strategy vs. usual care for crc screening.


Eligibility criteria:
inclusion criteria: * males and females * age 50-64 years * seen one or more times at a parkland primary care clinic within one year (index year) * participants in parkland's medical assistance program for the uninsured (parkland health plus) * all races and ethnicities exclusion criteria: * up-to-date with crc screening, defined by: 1. colonoscopy in the last 10 years 2. sigmoidoscopy in the last 5 years 3. stool blood test (fit) in the last year * prior history of crc, total colectomy, inflammatory bowel disease, or colon polyps * address or phone number not on file * incarcerated

Keywords: colorectal neoplasms colorectal cancer colon cancer mass screening health services research comparative effectiveness research
evaluation of length of stay after tf-tavi

Conditions: Severe Symptomatic Aortic Stenosis

Summary: transcatheter aortic valve implantation (tavi) has been rapidly adopted worldwide since the first-in-man tavi performed in 2002. with increasing experience and improvements in valve design, the "minimalist" approach to transfemoral tavi (using local anesthesia and fluoroscopic guidance) has become an attractive concept, and the technical feasibility of this approach has been well documented. while earlier data showed prolonged length of stay after tf-tavi \[10.5 ± 8.1 days in the france 2 registry and 10.2 ± 11.1 days in the partner cohort a data, the uk tavi registry (reference) showed a decline in post-tavi length of stay from 10 days to 8 days over the time period of 2007 to 2012. more contemporary data from other centers has been published showing that 23% of tf-tavi patients were discharged within 3 days after tavi. with an increasingly minimalist approach to tf-tavi, the duration of monitoring required post-procedure remains indeterminate with a lack of formal consensus. early discharge (within 3 days of tavi) is hypothesized to have multiple potential advantages, including reduction in unnecessarily lengthy hospitalization of frail and elderly patients in addition to cost-saving benefits. rouen university hospital has previously published a retrospective study on the feasibility and safety of early discharge, in which discharge within 72 hours of uncomplicated tf-tavi was safe and attained in 36% of our patients. pre-existing pacemaker and the absence of acute kidney injury were independent predictors of a successful early discharge. moreover, in a prospective study, rouen university hospital recently shown that early discharge afterelective tf-tavi with sapien-xt/sapien-3 prostheses was attainable in a large proportion of patients (59%) with no evident compromise in safety. factors associated with failure of early discharge were postprocedural blood transfusion and permanent pacemaker implantation. but currently, there are no guidelines for the length of stay after a tf-tavi.


Eligibility criteria:
inclusion criteria: * stable patients with severe symptomatic aortic stenosis * patient undergoing planned tf-tavi with the sapien-3 prosthesis, * tf-tavi using a minimalist approach of local anesthesia and conscious sedation exclusion criteria: * the use of other (than edwards sapien-3 or xt) transcatheter aortic valve devices. * tf-tavi requiring general anesthesia or surgical cut-down. * tf-tavi performed in unstable patients or on an urgent/emergent basis. * non-transfemoral routes of valve delivery (eg. transapical, transaortic, etc). * discharge back home impossible (including transfer in another hospital) * programmed transfer to another hospital

Keywords: transcatheter aortic valve implantation sapien-3 prostheses length of stay aortic stenosis